Apparatus for adminstering a therapeutic agent into tissue

ABSTRACT

An apparatus for administering a therapeutic agent is provided. The apparatus, in an embodiment, includes an ozone generator connected to a scavenger and an ozone administrator via network of tubing and valves. When activated and the valves placed in the proper position, the ozone generator will fill the ozone administrator with ozone. The ozone generator can then be turned off and the valves moved so that the administrator can be disconnected from the remainder of the apparatus. The administrator is typically in the form of a syringe and needle. Once the syringe and needle is filled with ozone, the needle can be inserted into a tissue and the ozone expressed therefrom into the tissue. Various other apparatuses and methods are also contemplated.

PRIORITY CLAIM

The present application is a divisional application of, and claimspriority to and the benefit of U.S. patent application Ser. No.10/867,215, filed Jun. 15, 2004, which claimed the benefit of andpriority to U.S. Provisional Patent Application No. 60/508,300, filedOct. 6, 2003. The contents of both of these prior applications areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to a method, apparatus and kitfor administering a therapeutic agent into tissue and in particular, forthe administration of a therapeutic agent such as medical ozone.

BACKGROUND OF THE INVENTION

Back joint disc or tendon pain is a common and potentially debilitatingailment that affects an estimated 80% of the worldwide population atleast once in a lifetime. In many instances, the cause of the pain canbe attributed to a degenerated intervertebral disc that has furtherdeteriorated into a condition known as disc herniation. This occurs whenthe disc nucleus pulposus extrudes through a tear or fissure in theouter lining of the disk, thereby exerting pressure on spinal nerves.The compression caused by the herniated nucleus leads to inflammationand is directly responsible for the pain felt down the leg (alsoreferred to as sciatica). Available treatments for this type of backpain vary according to the severity of the hernia. If mild, thepatient's condition can be appeased with rest and inactivity for anextended period of time. However, for patients suffering from a severeherniation or who do not respond to non-invasive treatment(pharmacological and/or physical therapy), surgical intervention isoften recommended. With this invasive treatment come severaldisadvantages such as:

-   -   i) irreversibility of the procedure    -   ii) formation of scar tissue    -   iii) slower recovery time    -   iv) longer hospital stays

Since the late 1950s, many attempts have been made to treat sciatica andlower back pain with percutaneous procedures to avoid surgery. Wellknown treatments for example are percutaneous discetomy andchemonucleolysis but the cost of these procedures has kept researcherslooking for another alternative. It was in 1984 that an Italianorthopedic surgeon by the name of Dr. Cesare Verga first proposed theuse of ozone/oxygen mixtures to treat the pathology of a herniated disk.(See for example, http://www.cleanairassociationlcom/6/ca_(—)3.htm,Ozone Therapy: New breakthrough for Back Treatment, by Gaetano Morello,M.D., the contents of which are incorporated herein by reference.)

Other prior art references include: Percutaneous Treatment of HerniatedLumbar Disc by Intradiscal Oxygen-Ozone Injection, M. Muto and F.Avella, Interventional Neuroradiology 4:279-286, 1998.

In other situations such as rheumatoid arthritis, osteoarthritis or arepetitive injury through sports or occupation, such as tennis elbow,frozen shoulder, or house maids knee, inflammation can develop betweentwo surfaces the are involved in allowing joint function, such as atendon and the sheath or lubricated tube in which that tendon moves.Inflammation such as bursitis in the knee shoulder hip, or otheranatomic bursa may benefit from ozone therapy; this includesepicondylitis, and other tendonitis and bursitis, including the wrist,hand and the tendon sheaths of the hand and wrist. Inflammation canoccur at a site where a tendon or a ligament insert to bone or passthrough a sheath from trauma, tension, over use or disease.

Inflammation can develop through pathologies of any joint, and these mayagain include the inflammatory arthropatic conditions of rheumatoidarthritis, psoriatic arthritis and the like, or osteoarthritis. Jointsthat may be involved in these processes that are amenable to ozoneinjection include the synovial joints such as the, temperomandibularjoint, the hip joint, knee joint, ankle joint, elbow joint orsacro-iliac joint. Vertebral facet and sacro-iliac joints may alsobenefit, inflammatory involvement of joints in the hand, wrist and feetwith rheumatoid arthritis, osteoarthritis or a repetitive injury throughsports or occupational such as carpal tunnel syndrome.

The inflammatory and arthritic or degenerative discussions describedabove are usually treated with a combination of anti-inflammatory agentssuch as ibuprofen, or more powerful drugs such as steroids orchemotherapy such as methotrexate. It is a common medical practice toinject steroid medications or lidocaine directly into the inflamedtissue or joint. This is often done repeatedly. These drugs can beassociated with side effects of infection and even death from gastriculcer bleeding or immunosurpression and infection. We believe that ozonetherapy whether as a liquid or a gas would have advantages over thecurrent practice.

Lavage of a surgical space prior to placement of a permanent surgicalimplant such as a hip or knee prosthesis, or pacemaker or treatment ofan infected joint can be facilitated by the use of medical ozone as asterilizing substance. Similarly a colostomy stoma can be created suchthat the adhesive disk is infused with ozone as a liquid or gas to aidin healing and inhibit infection. The post surgical recovery fromsternotomy after cardiac surgery is often complicated wound infection.Placement of a resorbable catheter in the wound that could be irrigatedwith ozone liquid or gas would aid healing. Indeed any wound could havea resorbable multisided hole catheter placed in it to allow ozone beinjected through it. This would have anti-infective, analgesic andpromote wound healing properties. This would shorten recovery time anddecrease complication rates after surgery.

Enhance liquid ozone could be applied to the wound/surgical site healingat a site of high probability of infection such an abdominalincision/wound after appendectomy, or urgent colectomy with colostomy orafter percutaneous endoscopic cholecystectomy.

Endoscopic procedural infusion of ozone and trans catheter infusion ofozone can be used to inhibit the complications endoscopic medicalintervention or image guided or non-image guided catheter basedintervention for example in endoscopic evaluation of the pancreaticduct.

Dental injection of liquid or gas ozone may augment the preparation andrepair of dental cavities, and aid in reduction of root canalinflammation or periodontal disease.

There are veterinary applications of minimally invasive ozoneadministration in animals diseased with disc and degenerative syndromes.Few other options are available in that arena. Some animals aredestroyed due to debilitating pain secondary to pain from disc disease,and arthritis.

While the full therapeutic potential of ozone continues to unfold withongoing research, it is already clear that this form of therapy for thetreatment of disc herniation has significant advantages over othersurgical and percutaneous procedures. Some of these advantages include:

-   -   fewer clinical and neuroradiological contraindications    -   success rates greater than about 70% in the intervertebral disc    -   little or no recovery time    -   little or no side effects    -   little or no scar tissue formed    -   minimally invasive procedure in    -   effective alternative treatment for which response to        conservative management, such as rest and reduced daily        activity, has failed to treat

As the success of ozone gas therapy continues to gain recognition in themedical arena as a non-invasive alternative for the treatment of discherniation, current methods of administering an effective dose of theozone are solely as a gas and are far from optimum. There also lacks asterile methodology through which the ozone can be delivered selectivelyto the pain-affected area, i.e. the herniated disk. The gas is unstablewith a half life measured in seconds. There are no dedicated medicalozone generators that are disposable single use units. In accordancewith this, there is a need for equipment especially designed for thetreatment of disc herniation and other medical conditions affecting thebody with medical ozone so that it can be done in an efficient andsterile manner. There is a need to develop kits for intervention ininflammatory and degenerative disease, that are disposable, or reusable,but aid in creating sterile, stable, ozone rapidly on demand. Thegeneration of ozone from sterile water would allow storage ofinjector/generators in all medical dental and veterinary facilities.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a novelapparatus and method for administering a gas into a tissue that obviatesor mitigates at least one of the disadvantages of the prior art.

In a first aspect of the invention there is provided a kit foradministering therapeutic gas mixture into soft tissue, wherein said gasmixture includes ozone. The kit can comprise of the following items:

-   -   Disinfectant    -   Drape    -   Skin preparation material    -   Local anaesthetics contained in vials    -   Syringes    -   Short and long needles, some with side holes    -   Gantry drape    -   Radiolucent needle holder    -   Nonionic x-ray dye-for discogram    -   Infusion wire    -   Charcoal ozone scavenger    -   Steroids contained in vials    -   A source of ozone either generated as a gas or a liquid in a        disposable single use unit that is sterilizable. The ozone can        be generated in the delivery system as a battery powered        electronic hand held disposable device    -   The ozone generator based in the injector will be available in a        variety of sizes, capable of delivering a range of ozone        volumes, from 1 cc to 5 cc, but could be made to generate        volumes of ozone liquid or gas form 0.1 cc to 1 liter.    -   It is probable that the commonly used volumes would be between 1        cc and 10 cc allowing for dead space in the connecting        tubing/needle etc.    -   Disposable filtered attachment    -   Stop cocks    -   Non-compliant tubing    -   Post-operative dressing for skin closure    -   Adhesive bandages with gauze pad in the centre

An example of a local anesthetic is, but not limited to, Lidocaine HCl

An example of a nonionic x-ray dye is, but not limited to, Omnipaque300M.

An example of a post-operative dressing is, but not limited to, Povidonegel.

Any suitable source of ozone can be used such as an ozone generator, theAOS-1M Medical Ozonator or AOS-1MS Stainless Medical Ozonator forexample, or a disposable injector filled with ozone.

In another aspect of the invention, there is a method for the treatmentof pain caused by a herniated disc and comprising of first identifyingthe herniated disk using an imaging technique and subsequently injectinga known volume of medical ozone into the disc and paraspinous softtissues in a sterile manner and environment.

In another aspect of the invention, there is provided an apparatus foradministering a therapeutic agent comprising a therapeutic agentgenerator and a scavenger connected to the generator via a first valvefor capturing the therapeutic agent. The therapeutic agent administratoris connectable to the generator via at least one additional valve suchthat when the valves are in a first position the generator communicateswith the administrator for filling the administrator with the agent.When the valves are in a second position the administrator retains theagent therein upon disconnection from the generator, and the scavengercaptures any excess agent intermediate the administrator and thegenerator.

The agent can be ozone in a gaseous mixture or dissolved in a liquid.The generator can be a medical ozone generator. The medical ozone can bea ratio of oxygen (O2) and ozone (O3).

The ratio of ozone in micro grams to oxygen in milliliters can be about1 μg/ml, or about 10 μg/ml, or about 20 μg/ml, or about 30 μg/ml, orabout 40 μg/ml, or about 50 μg/ml.

The ratio of ozone in micro grams to oxygen in milliliters can bebetween about 1 μg/ml and about 90 μg/ml. The ratio of ozone to oxygencan be between about 10 μg/ml and about 80 μg/ml. The ratio of ozone tooxygen can be between about 20 μg/ml and about 70 μg/ml. The ratio ofozone to oxygen can be between about 10 μg/ml and about 34 μg/ml. Morepreferably, the ratio of ozone to oxygen can be between about 27 μg/mlto about 28 μg/ml.

The administrator can be a syringe.

Another aspect of the invention provides a method of treating the paincaused by a herniated disc comprising identifying the herniated disk andinjecting medical ozone into the disc and paraspinous soft tissues.

Another aspect of the invention provides a syringe for self-containedgeneration and administration of a therapeutic agent comprising a barrelfor holding the agent, and a plunger for insertion into a first end ofthe barrel and expressing the agent from a second end of the barrel. Thesyringe also includes a power supply integrally mounted coaxially withthe plunger. The syringe also includes a therapeutic agent generatorintegrally mounted coaxially with the plunger and in communication withthe barrel through a channel in the plunger. The generator is connectedto the power supply and mounted coaxially with the plunger. The syringealso includes a switch connected to the power supply such that when theswitch is activated the therapeutic agent generator generates thetherapeutic agent and fills the barrel therewith.

In another aspect of the invention the ozone can be generated either asa liquid or a gas, in a syringe type structure where the electronics arehoused in the area normally occupied by the plunger of the syringe andthe anode is in the syringe. The syringes can be any desired volumes,such as those ranging from 1 cc to 60 cc, more preferably 1 cc to 10ccs. The syringes are typically made of polyethylene to resist thecorrosive effect of ozone even in the short time it in contact with theplastic.

Another aspect of the invention provides an implantable apparatus forself-contained generation and administration of a therapeutic agentcomprising: a chamber for holding the agent and a catheter forconnecting the chamber to an area for administration of the agent. Theapparatus also includes a power supply and a therapeutic agent generatorin communication with the chamber, the generator connected to the powersupply. The apparatus also includes a switch activatable externally by apatient implanted with the apparatus. The switch is connected to thepower supply such that when the switch is activated the therapeuticagent generator generates the therapeutic agent and fills chambertherewith.

Another aspect of the invention provides a method of treating paincaused by a herniated disc comprising of the following steps:

-   -   identifying the herniated disk with an imaging device;    -   preparation of the skin above the affected area;    -   applying local anaesthetics to the operation site;    -   inserting a needle down to the disc level at the herniated disc;    -   injecting nonionic x-ray dye down the needle;    -   performing a discogram of the disc;    -   activating an ozone generator external to the patient;    -   selecting a specific concentration of O3/O2 gas mixture on the        ozone generator;    -   attaching a scavenger and a syringe to the ozone generator;    -   aspirating the O3/O2 gas mixture into the syringe;    -   injecting a predetermined volume of a fixed concentration of        ozone/oxygen gas mixture into the disc and paraspinous soft        tissues of the disc;    -   capturing unused ozone in the charcoal scavenger; and,    -   removing all needles;    -   dressing the operative site.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention will now be discussed, by way ofexample only, with reference to the attached Figures, in which:

FIG. 1 shows an apparatus for administering a gas into a tissue inaccordance with an embodiment of the invention;

FIG. 2 shows the hip area of a patient where a therapeutic agent can beadministered;

FIG. 3 shows the spinal disc area of a patient where a therapeutic agentcan be administered;

FIG. 4 shows a normal spinal disc;

FIG. 5 shows a herniated spinal disc where a therapeutic agent can beadministered;

FIG. 6 shows an apparatus for administering a gas into a tissue inaccordance with another embodiment of the invention;

FIG. 7 shows the administrator of FIG. 6 with the needle placed thereon;

FIG. 8 shows an apparatus for administering a gas into a tissue inaccordance with another embodiment of the invention;

FIG. 9 shows an apparatus for administering a therapeutic agent into ahip region in accordance with another embodiment of the invention;

FIG. 10 shows the apparatus of FIG. 9 in greater detail;

FIG. 11 shows an infusion wire through which a therapeutic agent can beadministered;

FIG. 12 shows the infusion wire being passed through a needle towardsthe centre of a herniated disc;

FIG. 13 shows the infusion wire being placed in centre of a herniateddisc with the needle having been removed;

FIG. 14 shows the infusion wire of FIG. 11 in greater detail; and,

FIG. 15 shows an apparatus for administering a therapeutic agent into atissue in accordance with another embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, an apparatus for administering a therapeuticagent, such as an ozone gas, into a tissue in accordance with anembodiment of the invention is indicated generally at 20. In a presentembodiment, apparatus 20 comprises an ozone generator 24 that connectsto a charcoal scavenger 28 and an ozone administrator 32. Generator 24can be based on any known medical ozone generator. Generator 24 connectsto scavenger 28 and administrator 32 via a network of flexible tubingand valves for selectively directing the flow of gas there between. Morespecifically, a first segment of tubing 36 connects generator 24 to athree-way valve 40. A second segment of tubing 44 connects valve 40 toscavenger 28. A third segment of tubing 48 connects valve 40 to anothervalve 52, which in turn connects to administrator 32. The tubing is madeof any suitable material, such as silicon of the known medical type, andhas a diameter and wall thickness to withstand the pressure of ozone gasbeing carried there through. The valves, also known as stopcocks, arealso of the known medical type and have fittings complementary to thevarious portions of tubing.

Administrator 32 is comprised of a syringe 56, a three-way valve 60, anda needle 64. Syringe 56 is typically made of polyethylene to resist thecorrosive effect of ozone, but other materials will occur to those ofskill in the art. Three-way valve 60 is releasably connectable directlyto valve 52, providing a selective pathway between syringe 56 andgenerator 24 and/or scavenger 28.

Valve 40 has a first position wherein generator 24 communicates onlywith tubing 48. Valve 52 has a first position wherein tubing 48communicates with administrator 32. Valve 60 has a first positionwherein syringe 56 communicates only with tubing 48. Thus, when valves40, 52 and 60 are all in the first position, generator 24 is incommunication with syringe 56, and thus when generator 24 is “on”,syringe 56 will be filled with ozone. (It is to be noted that in of theFigures attached hereto, for this embodiment subsequent embodiments, thevarious valves depicted therein are not intended to be shown in anyspecific position, and are merely illustrated to show their physicalorientation in relation to the rest of the components in the apparatus.)

Valve 40 has a second position wherein tubing 44 communicates with bothtubing 36 and 48. Valve 52 has a second position wherein tubing 48 iseffectively capped, preventing communication between administrator 32and tubing 48. When valves 40 and 52 are in the second position, anyozone generated by generator 24 is captured by scavenger 28. In apresent embodiment, scavenger 28 is of the charcoal type, but any typeof scavenger for capturing excess ozone can be used.

Once generator 24 is turned “off” after filling syringe 56 as describedabove, then when valves 40 and 52 are each moved from their respectivefirst position to their respective second position then any excess ozonestill present in tubing 48 and 36 will be captured by scavenger 28 andthereby reduce and/or substantially eliminate the unwanted escape ofozone into the atmosphere where it may harm the operator or otherindividuals proximal to apparatus 20.

Valve 60 also has a second position wherein syringe 56 is prevented fromcommunicating with either valve 52 (or the open fitting on valve 60 thatconnects to valve 52), or with needle 64. Thus, once syringe 56 has beenfilled with ozone, leaving administrator 32 ‘charged’ with ozone, valve60 will also be placed in its second position to retain the ozone withinsyringe 56 once administrator 32 is disconnected from valve 52.

Once administrator 32 is charged with ozone, it can be disconnected fromthe remainder of apparatus 20 so that it can be used to administer ozoneto a target area. Thus, valve 60 also has a third position that placessyringe 56 in communication with needle 64. Referring now to FIG. 2,when charged, valve 60 can be placed in the second position to preventozone from escaping from syringe 56. Administrator 32 can then bedisconnected from the remainder of apparatus 20 and then needle 64 canbe inserted into tissue (or other target area) where the ozone is to beadministered. In FIG. 2, needle 64 is shown inserted into a hip 68.Having inserted needle 64 into hip 68, valve 60 is placed in the thirdposition, allowing syringe 56 to communicate with needle 64. At thispoint syringe 56 is depressed, and the ozone gas therein is expressedout of needle 64 into hip tissue, thereby providing localized painrelief around hip 68. Such administration of ozone can be helpful torelieve pain after some types of hip surgeries, such as hip replacement,or after bone is harvested from the pelvis to use as a bone graftmaterial.

Other types of localized pain relief can also be provided. While FIG. 2depicts pain relief being provided to hip 68, FIG. 3 depicts theprovision of pain relief to a spinal disc 72. By way of background, asseen in FIG. 4 a normal disc is shown in cross section at 72 n. Disc 72n has an outer annulus fibrosus 76 n, an inner annulus fibrosus 80 n, atransition zone 84 n, and a nucleus pulposus 88 n. However, in FIG. 5,disk 72 is also shown in cross section, wherein nucleus pulposus 88 isprotruding, and thereby a cause of pain. However, the administration ofozone into the protruding nucleus pulposus 88 using administrator 32 vianeedle 64 pain can be relieved and/or substantially eliminated at leasttemporarily.

It should now be apparent that having administered ozone fromadministrator 32, administrator 32 can then be reconnected to theremainder of apparatus 20, and the appropriate valves 40, 50 and 62adjusted to either allow any remaining ozone to be expressed fromadministrator 32 for capture by scavenger 28, or to refill syringe 56.

Referring now to FIG. 6, an apparatus for administering a gas into atissue in accordance with another embodiment of the invention isindicated generally at 20 a. Apparatus 20 a includes many similarcomponents to apparatus 20, and like components are indicated with likereferences but followed by the suffix “a”. In contrast to apparatus 20,however, administrator 132 a includes certain differences fromadministrator 32. Specifically, administrator 132 a has a two way valve160 a, one end of which connects to syringe 132 a, the other end ofwhich has a fitting to allow administrator 132 a to be connected toeither valve 52 a, as shown in FIG. 6, or to needle 164 a as shown inFIG. 7. When administrator 132 a is connected to valve 52 a as shown inFIG. 6, valves 52 a and 160 a can be placed in an open position so thatsyringe 132 a communicates with generator 24 a. When generator 24 a is“on”, syringe 132 a will be filled with ozone. Once syringe 132 a isfilled with ozone, valves 52 a and 160 a can be placed in the closedposition, and valve 40 a can be turned so that once apparatus 160 a isdisconnected from valve 52 a, any ozone remaining in tubes 48 a, 36 a orelsewhere in that remaining portion of apparatus 24 a can be captured byscavenger 28 a.

Having filled syringe 132 a with ozone, and closed valve 160 a, needle164 a can then be affixed thereto as shown in FIG. 7. Valve 160 a canthen be selectively opened or closed to allow the administration ofozone to tissue, in much the same manner as previously described inrelation to FIGS. 2 and 3.

Referring now to FIG. 8, an apparatus for administering a therapeuticagent into tissue is indicated generally at 20 b. Apparatus 20 b is aself-contained, portable version of apparatuses 20 and 20 a.Specifically, apparatus 20 b includes a needle 164 b and a two-way valve160 b that are substantially the same as needle 164 a and valve 160 a asdescribed above. Apparatus 20 b also includes a syringe 132 b comprisinga barrel 156 b (or other chamber) and a plunger 192 b (or other means toexpress the contents of the chamber). Plunger 192 b is configured as anormal plunger on a syringe, but also includes a miniature ozonegenerator 196 b mounted on the shaft of plunger 192 b. In turn, ozonegenerator 196 b is connected to a power supply 200 b and an on-offswitch 204 b that is disposed on the exterior tip of the shaft ofplunger 192 b. A small channel 208 b joins generator 196 b to theopposite tip of the shaft of plunger 192 b, such that when plunger 192 bis disposed in barrel 156 b, generator 196 b is in communication withthe interior of barrel 156 b. In this manner, switch 204 b can beactivated and thereby cause ozone to be generated and fill barrel 156 b.Of particular note, in the present embodiment ozone can be generated ineither gaseous or liquid form.

While switch 204 b is activated, it is generally desired to have valve160 b placed in the closed position to prevent ozone from flowing frombarrel 156 b into needle 164 b. Once a sufficient or otherwise desiredamount of ozone has been generated and filled barrel 156 b, switch 204 bis turned “off” to discontinue generation of ozone, and then apparatus20 b is used in much the same manner as administrator 32 as describedabove in relation to FIGS. 2 and 3. The ozone generator 196 b can beprovided in a variety of sizes, capable of delivering a range of ozonevolumes, for example from about one cc to about five cc, but could bemade to generate volumes of ozone liquid or gas form of about 0.1 cc toabout one liter.

Referring now to FIGS. 9 and 10, an apparatus for administering atherapeutic agent into tissue is indicated generally at 20 c. Apparatus20 c is a self-contained, implantable version of apparatuses 20, 20 aand 20 b. As shown in FIG. 9, apparatus 20 c is implanted subcutaneouslyproximal to hip 68. In a present embodiment, apparatus 20 c includes aseparate, external switchable power supply 212 c that is disposed justabove the skin of the patient and is thereby activatable on demand bythe patient. Power supply 212 c connects to a miniature ozone generator196 c disposed percutaneously. In turn, generator 196 c is connected toan oxygen source 220 c, such that when power supply 212 c is “on”,generator 196 c will interact with source 220 c of either oxygen orsterile water, to generate ozone in either in liquid or gaseous form,inside a cavity 224 c. In turn, cavity 224 c is connected to a catheter228 c, which interconnects with cavity 224 c with the tissue inside hip68 to which the ozone is being administered to relieve pain associatedtherewith.

As a variation of apparatus 20 c, power supply 212 c can be disposedsubcutaneously, and a wireless switching means can be disposed on theoutside of the patient, such as a magnetic switch or other types ofwireless means for activating or deactivating the ozone generator.Advantageous to this technique is that the overall use of needles isdiminished, and thus beam hardening artifacts that are generated bymetallic objects that can prevent proper visualization of the discdetails (as might occur when doing injections by means of imageguidance, and as may be done in certain other embodiments herein,) arereduced. In sum, by reducing the use of needles, visualization isimproved and allows the dorsal root ganglion to be clearly seen.

Referring now to FIGS. 11-14, in another variation an infusion wire 232d is passed through needle 168 d until it coils inside nucleus pulposus88 (or other tissue area for treatment.) Since infusion wire 232 d isperforated along its length, as shown in FIG. 14, once a desired orsufficient amount of wire 232 d has been inserted into nucleus pulposus88, an ozone source can be connected to the opposite end of the infusionwire 232 d and injected into nucleus pulposus 88 via the infusion wire.Due to the perforations along infusion wire 232 d, ozone is dispersedmore readily into nucleus pulposus 88.

Referring now to FIG. 15, in another variation of the foregoingembodiments, it can be seen that various other configurations of howadministration of the ozone are within the scope of the invention.Specifically, FIG. 15 shows a syringe 132 e connected to a valve 160 evia tubing 232 e.

In another embodiment of the invention, a kit of parts for performing aninjection of medical ozone for the treatment of a herniated disc or thelike. The kit includes a sterile tray with a number of compartments tohold:

-   -   a disinfectant, drape and skin preparation material,    -   lidocaine and a 10 cc syringe with a 22-G long needle,    -   nonionic x-ray dye-for discogram such as Omnipaque 300 M,    -   outer 16 or 18 G needle to act as the co-axial introducing        needle,    -   20 or 22 G needle with possible side holes for injecting the        ozone into the disc,    -   outer large needle of 16-18 G for steroid injection (can also be        used to inject ozone into the paraspinous soft tissue),    -   an infusion wire for even distribution of the ozone into the        disc space    -   a charcoal ozone scavenger (a bottle with charcoal and 100% 0₂),    -   steroids and local anaesthetics contained in a vial, ready for        injection,    -   a source of ozone such as a generator, examples include the        AOS-1M Medical Ozonator or AOS-LMS Stainless Medical Ozonator,        or a disposable injector in which then ozone can be generated        filled with ozone,    -   a disposable filtered attachment for the syringe a one way stop        cock attached to the ozone generator,    -   connecting, non-compliant tubing of 20-30 cm in length to reduce        radiation to the operator hands during injection under image        guidance.    -   a three-way stop cock linking the tubing to the charcoal ozone        scavenger bottle    -   a one-way stop cock linking the tubing to the syringe via the        said disposable filtered adapter,    -   pharmaceutical gel such as Povidone, and    -   adhesive bandages with a gauze pad in the center, such as        Band-aid, or small dressing.

In another embodiment of the invention, there is a method consisting offirst introducing the patient into the computer tomography (“CT”)scanner and performing a diagnostic CT scan in order to identify theherniated disc such as disc 72. The CT gantry is subsequently draped andreadied, the skin is prepared and local anesthetic is applied to theskin and adjacent soft tissue. A 16-18 G needle is pinned down to thedisc level and a 22 G needle is inserted into the disc. A discogram isperformed to check symptoms by injection of x-ray dye. The ozoneapparatus (in the form of any of the previously described apparatus orsuch other apparatus as may now occur to those of skill in the art) issubsequently switched on and the ozone/oxygen concentration chosen. Theratio of ozone/oxygen mixtures to choose from are about 0 μg/ml, about10 g/ml, about 20 μg/ml, about 30 μg/ml, about 40 μg/ml or about 50μg/ml A presently preferred range is between about 10 μg/ml and about 34μg/ml, but more preferably about 27 μg/ml to about 28 μg/ml. In otherembodiments other gases or therapeutic agents can be used, such as pureoxygen if found to be therapeutically effective or desirable.

As a next step, the syringe is fitted with a disposable filteredattachment which is itself attached to 20-30 cm of non-compliant tubingfitted with a 3-way to cock on one end and a one-way stop cock on theother, such as that shown in FIG. 15. Ozone gas is then aspirated intothe 10-cc syringe (can also use a calibrated cardiac syringe) via thedisposable filtered adapter and the connecting tubing such that theentire dead space is filled with a known concentration of ozone. Thetotal volume of dead space should be known so appropriate amounts ofozone are actually injected to the desired area. CT fluoro imaging orthe like can be subsequently used to inject the ozone into the disc andparaspinous soft tissues. An infusion wire with a stiff stylet could beused, as previously described. Once the ozone injection is completed, astop cock on the connecting tubing is closed. All of the leftover ozoneis injected into the charcoal scavenger or a pure oxygen tube/bottleattached to the connecting tubing via a Luer lock. Steroids are theninjected through the coaxial outer large needle. Finally, all needlesare removed, the skin is appropriately dressed and a bandage is used tocover the perforated skin.

In another embodiment of the invention, there is provided the combinedintradiscal and periganglionic injection of medical ozone andperiganglionic injection of steroids which has a cumulative effect andenhances the overall outcome of treatment.

While only specific combinations of the various features and componentsof the present invention have been discussed herein, it will be apparentto those of skill in the art that desired subsets of the disclosedfeatures and components and/or alternative combinations of thesefeatures and components can be utilized, as desired. For example, othertypes of pain can be treated using the teachings herein. For example,joints, tendons, ligaments are other areas that can be treated. Anotherexample includes irrigating a wound site, such as a colostomy, withozone to reduce pain at the wound site. As another example, animplantable device could put into the teeth (or other dental area) of apatient, similar to apparatus 20 c to reduce pain in the dental region.As another example is to irrigate a subcutaneous pouch for holding apacemaker or the like for sterilization and/or treatment of pain and/ordecrease of inflammation and such other advantage corresponding to thetherapeutic agent as will occur to those of skill in the art.

The above-described embodiments of the invention are intended to beexamples of the present invention and alterations and modifications maybe effected thereto, by those of skill in the art, without departingfrom the scope of the invention which is defined solely by the claimsappended hereto.

1. An apparatus for administering a therapeutic agent comprising: atherapeutic agent generator; a scavenger in operable communication withthe therapeutic agent generator; a therapeutic agent administrator inoperable communication with the therapeutic agent generator and thescavenger; and at least one valve positioned between the therapeuticagent generator and the therapeutic agent administrator, such that byoperation of the at least one valve, the administrator can be filled andexcess therapeutic agent can be captured by the scavenger.
 2. Theapparatus of claim 1, wherein said therapeutic agent comprises ozone. 3.The apparatus of claim 2, wherein said therapeutic agent comprisesoxygen.
 4. The apparatus of claim 1, wherein said generator comprises amedical ozone generator.
 5. The apparatus of claim 2, wherein said ozonecomprises gaseous medical ozone comprising a ratio of ozone (O₃) tooxygen (O₂).
 6. The apparatus of claim 5, wherein said ratio of ozone tooxygen comprises about 1 μg/ml.
 7. The apparatus of claim 5, whereinsaid ratio of ozone to oxygen comprises about 10 μg/ml.
 8. The apparatusof claim 5, wherein said ratio of ozone to oxygen comprises about 20μg/ml.
 9. The apparatus of claim 5, wherein said ratio of ozone tooxygen comprises about 30 μg/ml.
 10. The apparatus of claim 5, whereinsaid ratio of ozone to oxygen comprises about 40 μg/ml.
 11. Theapparatus of claim 5, wherein said ratio of ozone to oxygen comprisesabout 50 μg/ml.
 12. The apparatus of claim 5, wherein said ratio ofozone in micrograms to oxygen in milliliters is between about 1 μg/mland about 90 μg/ml.
 13. The apparatus of claim 12, wherein said ratio ofozone in micrograms to oxygen in milliliters is between about 10 μg/mland about 80 μg/ml.
 14. The apparatus of claim 13, wherein said ratio ofozone in micrograms to oxygen in milliliters is between about 20 μg/mland about 70 μg/ml.
 15. The apparatus of claim 14, wherein said ratio ofozone in micrograms to oxygen in milliliters is between about 10 μg/mland about 34 μg/ml.
 16. The apparatus of claim 15, wherein said ratio ofozone in micrograms to oxygen in milliliters is between about 27 μg/mlto about 28 μg/ml.
 17. The apparatus of claim 5, wherein saidadministrator comprises a syringe.
 18. The apparatus of claim 1, furthercomprising two valves for controlling the flow of therapeutic agentbetween the therapeutic agent generator, the scavenger and thetherapeutic agent administrator.
 19. The apparatus of claim 18, whereina combination of closing and opening each of the valves allows passageof therapeutic agent between the therapeutic agent generator and thetherapeutic administrator without allowing therapeutic agent to accessthe scavenger.
 20. The apparatus of claim 18, wherein a combination ofclosing and opening each of the valves allows passage of therapeuticagent between the therapeutic agent in the therapeutic administrator orbetween the therapeutic agent generator and the therapeuticadministrator to access the scavenger.
 21. An apparatus foradministering a therapeutic agent comprising: a therapeutic agentgenerator; a scavenger in operable communication with said generator viaa first valve for capturing said therapeutic agent; and a therapeuticagent administrator connectable to said generator via at least oneadditional valve, such that when said valves are in a first positionsaid generator communicates with said administrator for filling saidadministrator with said agent and when said valves are in a secondposition said administrator retains said agent therein upondisconnection from said generator and said scavenger captures any excessagent intermediate said administrator and said generator.